Staff Engineer, Advanced Technology Group

Directly responsible for the development of new products and or the enhancement of existing products associated with SafeOpTM integrated software and hardware neuromonitoring and Alpha InformatixTM adjunctive technology platforms. Lead or serve as a member of a project team. Involved in creating designs, modeling and drafting utilizing a 3D CAD system. Other responsibilities include assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project. Generate protocols for testing new and current products. Develop quality control procedures and inspection methods, and provide technical expertise in support of FDA 510K submissions.

Essential Duties and Responsibilities

• Independently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instruments.
• Leads the development of new products and manufacturing processes and/or serves as a key member of a project team.
• Responsible for the development of prototype models for evaluation by design surgeons.
• Establishes protocols for testing and analyzing new and current products.
• Directly responsible for the assurance documentation for the projects.
• Directly responsible for the Designing and developing of new products utilizing Solidworks CAD software
• Provides support to current products manufactured in house or by outside vendors
• Facilitates new projects from concept through production.
• Assisting Regulatory, by providing necessary documentation for FDA submissions. Provides engineering support to Manufacturing, Quality Control, Marketing, and Sales as necessary
• Knowledge of maintaining budgets and project costing.
• Other duties as assigned.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Experience with 3D CAD system, FEA Analysis preferably Solidworks,
• Expert experience with of product design and project development with general knowledge of device testing.
• Extensive experience in orthopedics, or closely related medical device industry
• Extensive experience of manufacturing methods, using multiple implantable grade materials.
• Extensive experience in the use and interpretation of geometric dimensioning and tolerancing
• Must be detail oriented, an effective communicator, and able to work within a team environment
• Excellent organizational skills
• Solid experience in leading multiple project teams concurrently with successful completion.
• Project costing or Managerial Accounting experience.

Education and/or Experience:

Minimum Bachelor's degree from four-year College or university in Mechanical or Biomedical Engineering Master preferred. Minimum of 10 years experience must have a minimum of 5 in medical device product development environment. Would prefer experience be in Spine or Orthopedics.

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $135,000 to $170,000 Full-Time Annual Salary